Thiamine Supplementation in Heart Failure Patients Receiv... | NCT01115504

Studies
Thiamine Supplementation in Heart Failure Patients Receiving Full Medical Therapy

NCT01115504

Sponsor

Mashhad University of Medical Sciences

Status

Completed

Last Update Posted

Dec 23, 2010Estimated

Enrollment

50Estimated

Phase

Phase 3

Conditions

Chronic Heart Failure

Interventions

Thiamine

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Nov 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

May 3, 2010

First Submission Date that Met QC Criteria

May 3, 2010

First Posted Date

May 4, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 22, 2010

Last Update Posted Date

Dec 23, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study is performed to consider the effect of thiamine supplementation on symptoms and signs of patients with heart failure and systolic and diastolic function of left ventricle.

Detailed Description

The study is performed to consider the effect of thiamine supplementation versus placebo on symptoms and signs of patients with heart failure systolic and diastolic function of left ventricle.

Heart failure patients (left ventricular ejection fraction (LVEF ≤ 40%) are randomized to receive tablets of 300mg or placebo for 1 months in a double-blind fashion. All subjects will be on stable optimal medical therapy according to the present guidelines for at least 3 months before enrolment. At randomization and at study end, echocardiography by a single observer will be performed and assessment of symptoms and signs and quality of life based on self scoring system (from 1 to 7) and objective physical examinations will be done.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Thiamine	Experimental	Thiamine tablets of 300mg are prescribed for 1 months	Drug: Thiamine
Plascebo	Placebo Comparator	Tablets of 300mg placebo are prescribed for 1 months	Drug: Thiamine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Thiamine	Drug	300 mg daily for 30 days	Plascebo Thiamine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dyspnea score	scores are given by the patients from 1 to 7 to dyspnea and are reevaluted after 30 days of intervention	30 days

Secondary Outcomes

Measure	Description	Time Frame
Edema score	Edema is scored 1 to 7 by a physician and reevaluated 30days later after intervention	30 days
Systolic function	ejection fraction, lateral and septal Sm wave (measured by tissue doppler) are evaluetad by echocardiography before and after intervention.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Heart failure patients (left ventricular ejection fraction (LVEF ≤ 40%)
Optimal medical therapy according to the present guidelines for at least 3 months before enrollment.

Exclusion Criteria:

Decompensated heart failure
Renal failure
COPD
Asthma
Uncontrolled hypertension
Bradycardia or tachycardia which needs increase or decrease in medications

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mehdi Mousavi, Cardiologist	Azad university	Study Chair
Said Namazi, MD	Azad university	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of medicine, Azad university		Shahrood	Semnan Province		Iran

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013831	Thiamine

Ancestor Terms

ID	Term
D013844	Thiazoles
D013457	Sulfur Compounds
D009930	Organic Chemicals
D001393	Azoles

Browse Leaves

Not provided

Browse Branches

Not provided